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Patient Safety Associate
hace 2 meses
We are seeking a highly skilled Patient Safety Senior Associate to join our Clinical, Medical & Regulatory department at Novo Nordisk. As a key member of our team, you will play a critical role in ensuring the safety and efficacy of our products.
Key Responsibilities- Receipt, documentation, triage, and quality assessment of inbound safety information, including adverse events and technical complaints.
- Ensuring compliance with all internal and external drug and device safety reporting requirements regarding the collection and maintenance of safety information.
- Conducting duplicate searches, product coding, and narrative generation.
- Handling inbound and outbound calls and correspondence for adverse events and technical complaints, providing professional and timely responses to product information questions and inquiries.
- Assisting with training and mentoring of new joiners and assisting with workload distribution and coordination.
- Identifying opportunities for development of procedures and making recommendations to management and support implementation of solutions.
- Bachelor's degree in a science or healthcare discipline.
- 3+ years of patient safety experience, preferably with customer service experience.
- Strong knowledge of medical and pharmacovigilance terminology.
- Experience with MedDRA coding and adverse event identification is preferred.
- Advanced or fluent level of Spanish and English.
- Familiarity with FDA regulations, computer validation, and Sarbox regulatory requirements.
- Proficiency in test case writing and execution is a must.
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. We are committed to promoting and being an equal opportunity workplace and acting as an affirmative action employer, as part of our continuous efforts to create and lead teams that have diversity and inclusion at their core.
